Can ILR Reduce the Risk of Arm Lymphedema?

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer Lymphedema
• Interventions: Procedure: Immediate lymphatic reconstruction

• Registration Number: NCT05742945
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Breast cancer-related lymphedema (BCRL) is a debilitating, usually lifelong burden for breast cancer survivors. For the breast cancer patients receiving axillary lymph node dissection (ALND), the likelihood of BCRL is about 20%. Lymphatico-venous anastomosis (LVA) has been accepted as a method of treating extremity lymphedema. A few studies have mentioned the prophylactic effect of LVA on BCRL. However, there is still lack of a large-scale randomized controlled trial to corroborate its efficacy. Therefore, the goal of this study is to conduct a prospective randomized controlled trial to evaluate if immediate lymphatic reconstruction (ILR) with LVA could have a clinically significant effect on the reduction of BCRL occurrence.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-14
• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-24
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-17
• Last Update Posted: 2024-03-19
• Primary Completion: 2028-08
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

1. Female patients with unilateral breast cancer
2. Going to receive axillary lymph node dissection, or sentinel lymph node biopsy but being highly suspected of axillary metastasis preoperatively

Exclusion Criteria

1. Had received axillary lymph node dissection
2. Going to receive bilateral axillary lymph node dissections
3. Already have arm lymphedema
4. Allergy to the dye used intraoperatively

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ILR	Immediate lymphatic reconstruction	Breast cancer patients receiving axillary lymph node dissection and immediate lymphatic reconstruction

Primary Outcome Measures

Name	Time	Method
Arm lymphedema	Two years	Occurrence of arm lymphedema

Secondary Outcome Measures

Name	Time	Method
Drainage amount	Two weeks	Drainage amount from operative wounds
Seroma or lymphocele	One month	Occurrence of seroma or lymphocele
Subclinical lymphedema	Two years	Occurrence of subclinical lymphedema
PROM	Two years	Patient reported outcome measures by LYMPH-Q Upper Extremity Module

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan